Bupropion (Includes Forfivo XL) ↔ liver disease

Bupropion is primarily metabolized by the liver. The systemic exposure and half-life of bupropion and its metabolites may be increased in patients with hepatic impairment, and drug accumulation may occur to a greater extent than usual. Therapy with bupropion should be administered cautiously in patients with impaired hepatic function, including mild to moderate hepatic cirrhosis. A reduced dose and/or dosing frequency should be considered. Extreme caution is advised in patients with severe hepatic cirrhosis. A dosage reduction is required in these patients, and the dosage should not exceed 75 mg once a day. All patients with hepatic impairment should be closely monitored for possible adverse effects that could indicate high drug or metabolite levels.

Bupropion (Includes Forfivo XL) ↔ seizure disorders

The use of bupropion is contraindicated in patients with a seizure disorder. Bupropion may trigger seizures in a dose-dependent manner up to a frequency of 0.4% at 450 mg/day, the maximum recommended dosage. The incidence of seizures increases dramatically at higher dosages (almost 10-fold at 600 mg/day). Because of the wide variability in individual capacity to metabolize drugs and the disproportionate increase in seizure incidence with dosage escalation, bupropion should not be used in patients with underlying seizure disorders. The use of bupropion is also contraindicated in patients with a current or prior diagnosis of bulimia or anorexia because of a higher reported incidence of seizures in such patients treated with the drug. Therapy with bupropion should be administered extremely cautiously in patients with other predisposing factors for seizures, including underlying neurologic abnormalities such as head trauma, brain damage or CNS tumor; excessive use of or abrupt withdrawal from alcohol; addiction to opiates, cocaine, or stimulants; diabetes treated with oral hypoglycemic agents or insulin; and concomitant use of medications that lower seizure threshold. A more gradual titration may be appropriate.

Adult and pediatric patients with depression and other psychiatric disorders may experience worsening of their symptoms and may have the emergence of suicidal thoughts and behavior. Patients should be monitored appropriately and observed closely for worsening of their symptoms, suicidality or changes in their behavior, especially during the first few months of treatment, and at times of dose changes. Discontinuing the medication should be considered if symptoms are persistently worse, or abrupt in onset.

Moderate

Antidepressants (Includes Forfivo XL) ↔ angle closure glaucoma

Some antidepressants exert mydriatic activity that can induce increased intraocular pressure and result in angle-closure (narrow angle) glaucoma in a patient with anatomically narrow angles who does not have a patent iridectomy. Prior to initiating therapy with these agents patients should be examined to determine whether they are susceptible to angle closure, and have a prophylactic procedure (e.g., iridectomy), if they are susceptible. The use of these drugs in patients with untreated anatomically narrow angles should be avoided.

Moderate

Bupropion (Includes Forfivo XL) ↔ mixed/manic episode

Therapy with bupropion may cause activation of mania and hypomania and should be used with caution in patients with personal or family history of mania, hypomania, bipolar disorder, and other mood disorders.

Moderate

Bupropion (Includes Forfivo XL) ↔ psychosis

Bupropion may precipitate or aggravate psychotic symptoms, including delusions, hallucinations, confusion, and paranoia. Depressed patients, usually those with bipolar disorder, may experience a switch from depression to mania or hypomania. Patients with psychotic disorders should be monitored for exacerbation of symptoms during bupropion therapy, and the dosing reduced or discontinued and/or additional medications (e.g., tranquilizers) administered as necessary.

Bupropion (Includes Forfivo XL) ↔ renal dysfunction

Bupropion metabolites, some of which are pharmacologically active with one-fifth to one-half the potency of the parent drug, are excreted by the kidney. Although pharmacokinetic studies have not been conducted in patients with renal impairment, it is conceivable that bupropion and its metabolites may accumulate in such patients to a greater extent than usual. Therefore, therapy with bupropion should be administered cautiously in the presence of significant renal impairment. A reduced dose and/or dosing frequency should be considered, and patients should be closely monitored for possible adverse effects that could indicate high drug or metabolite levels.

Bupropion (Includes Forfivo XL) ↔ weight loss

The use of bupropion is associated with weight alterations. Both weight gain and weight loss may occur, although the latter is much more common. The incidence of weight loss greater than 5 pounds is approximately 28%, which may be undesirable in patients suffering from anorexia, malnutrition or excessive weight loss. Weight change should be monitored during therapy if bupropion is used in these patients.